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115.1 Organization Policy on IRB Records

November 2010

It is the policy of the Organization that the OHSR shall maintain documentation of all IRB activities in accordance with federal regulations 45 CFR 46.115 and 21 CFR 56.115.  The OHSR shall keep the following records:

1.      Copies of all research proposals (and when applicable, federal funding applications) reviewed and all materials and documents submitted with the proposals, including:

  • Scientific evaluations accompanying the proposals (when applicable)
  • Approved sample consent documents
  • Progress reports submitted by investigators,
  • Reports of injuries, complaints, and other events (whether anticipated or unanticipated)

2.      Minutes of IRB meetings that document pertinent discussions and decisions on research.  A minutes template shall be the mechanism to document:

  • Attendance at the meeting for each vote, including when an alternate member replaces a primary member
  • Conflict of interest determinations
  • Device risk determinations and the rationale behind them
  • Drug issues
  • Approvable categories for children, pregnant women/fetuses/prisoners, or other identified vulnerable populations
  • Justification for waiver or alteration of informed consent or documentation of informed consent
  • The basis for requiring changes in research or tabling or disapproving research
  • Summary the discussion of controverted issues and their resolution
  • Actions taken by the IRB
  • The vote on these actions including the number of members voting for, against, and abstaining
  • The approval period for initial and continuing review
  • The names of IRB members who leave the meeting because of a conflict of interest, including a statement that the conflict of interest is the reason for the absence
  • Justification of any deletion or substantive modification of information concerning risks or alternative procedures contained in a DHHS-approved sample consent document

3.      For the initial and continuing review of expedited research, the primary reviewer’s review sheet is the mechanism used to document:

  • The specific permissible expedited category
  • The description of actions taken by the reviewer
  • Any findings required under the regulations

4.      For exempt research, the notice of acknowledgement generated by the reviewer in the eIRB system documents the specific category of exemption.

5.      Copies of all continuing review activities.

6.      Copies of all correspondence between the IRB and investigators, DSMB, and other entities involved in the research or institutional officials (as applicable).

7.      A list of all IRB members, both primary members and alternates.  The list shall identify the member’s name, earned degrees, member category (non-scientist, physician scientist, or other scientist), research experience, experience and expertise applicable to IRB deliberations, knowledge of or experience working with vulnerable populations, employment or other relationship with the Organization, affiliation status (whether the member or an immediate family member is affiliated with the Organization), and other members for whom the IRB member may alternate.

8.      Written JHM IRB policies and operations procedures.

9.      Statements of significant new findings required to be provided to research participants as required by regulations.

All JHM IRB records associated with specific research proposals are retained indefinitely and stored in a manner which maintains strict confidentiality.  An off-site storage facility shall be used to store archived materials.  All records shall be accessible and available for inspection by authorized agency personnel at reasonable times and in a reasonable manner.